OSU Hospital System
Columbus, Ohio, 43210, United States
Location status: Recruiting
NCT Number: NCT07215221
The goal of this hybrid type 2 pilot trial is to understand the implementation and effectiveness of the TBI-RECOVER intervention model (e.g., brain injury screening, cognitive and behavioral challenges screening, and neurocognitive accommodations) on patient retention in outpatient substance use disorder treatment. We will evaluate whether an implementation strategy bundle (e.g., training/education, champions, audit & feedback, facilitation) improves provider use and sustainability of the TBI-RECOVER intervention, and also whether the TBI-RECOVER intervention improves patient symptoms and treatment retention.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Columbus, Ohio, 43210, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Provider Inclusion Criteria:
The TBI-RECOVER intervention model consists of three components: 1) a web-based brain injury and cognitive impairment screener using the Online Brain Injury Screening and Support System (OBISSS) of the National Association of State Head Injury Administrators, 2) brief education and information on traumatic brain injury and substance use disorders, and 3) neurocognitive accommodations, or compensatory strategies, for neurological impairment.
Other names: Neurologic Informed Care
The control condition includes a brief information and educational sheet on traumatic brain injury and substance use disorder, how these two conditions are connected with each other, and a list of suggested accommodations they can use in treatment.
Time frame: 1 year
The proportion of treatment sessions attended over one year.
Time frame: 1 year
The Behavior and Symptom Identification Scale (BASIS-24) measures six domains: (1) substance use, (2) impulsive/addictive behaviors, (3) relationships with self and others, (4) depression/anxiety, (5) daily living/role functioning, and (6) psychosis. Each item is rated on a 5-point Likert scale, where 0 = lowest symptom severity and 4 = highest symptom severity. Subscales and the overall score are summed and then divided by the number of non-missing items for a total score. There are no clinical cut-offs.
Time frame: 9 weeks
The General Self-Efficacy Scale (GSES) will be used to measure self-efficacy. GSES is a 10-item measure of self-efficacy used in research for patients in treatment for SUDs. Items are measured on a 4-point Likert scale, where 1 = "Not at all true" and 4 = "Exactly true." Items are summed for a total score, with higher scores equating to greater self-efficacy. GSES has strong psychometric properties (α = .76 - .90). GSES will be measured at baseline (after informed consent), 3, 6, and 9 weeks.
Time frame: 9 weeks
We will use the Patient Expectation Questionnaire (CEQ), as well as single-item questions. CEQ is a 6-item questionnaire, with items measured on a 1 to 9, where 1 = "not at all logical" and 9 = "very logical." Questions 4 and 6 are rated on a 0-100% scale. Higher scores equal higher cognitive engagement. We will also ask the following single-item questions to measure cognitive engagement: "I understand the goals of my treatment;" "My therapists' approach to providing care will help me reach my goals." Cognitive engagement will be measured at baseline (after informed consent), 3, 6, and 9 weeks.
Time frame: 9 weeks
We will use the Treatment Perceptions Questionnaire (TPQ),(52) a 10-item measure of treatment satisfaction. Items measured on a 5-point Likert scale, where higher sum scores equal greater satisfaction with treatment. TPQ will be measured once at 9 weeks.
Time frame: Up to 4 years
A provider-level measure of the number and proportion of providers who consent to participation relative to the total number of providers eligible.
Time frame: Up to 4 years.
We define and measure "Reach" using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. As specified in this framework, "Reach" is an implementation outcome measured as the percentage of patients who received the intervention. Therefore, we will identify patients who received the intervention using the electronic health record and the brain injury screening tool (OBISSS) used for this study. The monthly program census (the denominator for determining the percentage for this measure) will be pulled using the electronic health record. Using these data, proportions of patients who received the intervention each month will be calculated and used to measure "Reach."
Time frame: 1 year
The Fidelity Verification Review Process (FVRP) is a provider-level measure of adherence to implementation of each intervention component, and measured on a 4-point Likert scale, where 1 = "Excellent implementation," 2 = "Strong/sufficient implementation," 3 = "Improvement needed implementation," and 4 = "Serious implementation concerns."
Time frame: At 6-months during the Sustainment Phase
The Normalization Measure Development Questionnaire (NoMAD) will be used to measure maintenance of TBI-RECOVER implementation. NoMAD is a a program-level measure with 23-items assessing the level of familiarity, normalization, and utilization of TBI-RECOVER per provider report. Three questions encompass the level of familiarity and use of the intervention on a scale of 0-10, where 0 is "not familiar at all" or "not at all used" and 10 = "Feels completely familiar" or "Completely used/part of work." The remaining 20 questions relate to details of the use of the intervention on a 5-point Likert scale, where 5 = "strongly agree" and 1 = "Strongly disagree." Higher scores equal greater familiarity and maintenance of the intervention. Additional questions allow for the respondent to mark that the question is not relevant to their role, stage of implementation, or intervention."
Ohio State University
Other
Facilitation as a Strategy for Implementing the Novel TBI-RECOVER Intervention Into Substance Use Treatment: A Mixed Methods Hybrid Type 2 Effectiveness-Implementation Trial
Acronym: TBI-RECOVER
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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